None listed
Conditions
Interventions
Oral intake of the test product (8 tablets in a day
4 weeks).
Oral intake of the placebo product (8 tablets in a day
4 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: [1] Japanese males aged 40-64 years [2] Individuals who are healthy and are not received treatment of disease [3] Individual who are aware of male menopausal symptoms (ex. fatigue, lethargy, lethargy, or decreased libido) [4] Individuals whose written informed consent has been obtained [5] Individuals judged appropriate for the study by the principal
Exclusion criteria
Exclusion criteria: [1] Individuals whose AMS' total score is over 50. [2] Subjects who score 11 or more on QIDS-J. [3] Individuals using medical products. [4] Individuals with a history of mental illness, male menopause, sleep apnoea, benign prostatic hypertrophy, ED, hypertension, diabetes, taste disorder, anaemia, dyslipidaemia or treatment for a serious illness in the past one year. [5] Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [6] Individuals who are a patient or have a history of or endocrine disease. [7] Individuals who use a drug to treat a disease in the past 1 month. [8] Individuals whose BMI is over 30 kg/m2. [9] Individuals who are sensitive to test product or other foods, and medical products [10] Individuals who have a habit of or have been in a habit of continuously consumption of Food with Functional Claims, health foods or supplements claiming similar effects of the test product within the past one month, or who plan to ingest these foods during the test period. [11] Individuals who have a habit of or have been in a habit of continuously consumption of health-promoting foods , health foods or supplements containing high levels of ingredients that have been implied to have effects similar to those of the test product within the past one month, or who plan ingest these products during the test period. [12] Individuals who have a habit of or have been in a habit of continuously consumption of health-promoting foods, health foods or supplements claiming effects for sleep and physical fatigue within the past one month, or who plan ingest these products during the test period. [13] Individuals who excessively take alcohol. [14] Individuals who are a smoker. [15] Individuals with possible changes of life style during the test period. [16] Individuals who participated in other clinical studies in the past 3 months. [17] Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Salivary free testosterone at Week 4 (Week 0, Week 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| [1]Aging Males' Symptoms scale(1) [2]Salivary free testosterone at Week 2 (2) [3] Serum testosterone(3) [4] Japanese translation of profile of mood states (1) [5] Grip strength measurement (3) *Safety [1] Hematologic test. (3) [2] Blood biochemical test. (3) [3] Urine analysis. (3) [4] Blood pressure, pulsation. (3) [5] Weight, body fat percentage, BMI. (3) [6] Doctor's questions/Adverse events. (3) [7] Subject's diary. (4) *Other indexes [1] Baseline characteristics [2] Quick Inventory of Depressive Symptomatology:QIDS-J(5) [3] height measurement (1): Week 0, Week 2, Week 4 (2): Week 0, Week 2 (3): Week 0, Week 4 (4): From the first day of ingestion of a test material to the last day of the test (5):Week 0 | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed